UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037633 |
|---|---|
| Receipt number | R000042911 |
| Scientific Title | Trial of the effect of food ingredients and exercise on muscle function (SWE-2019-05-HBLOCO) |
| Date of disclosure of the study information | 2021/02/28 |
| Last modified on | 2021/12/07 17:47:00 |
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Basic information
Public title
Trial of the effect of food ingredients and exercise on muscle function (SWE-2019-05-HBLOCO)
Acronym
Trial of the effect of food ingredients and exercise on muscle function
Scientific Title
Trial of the effect of food ingredients and exercise on muscle function (SWE-2019-05-HBLOCO)
Scientific Title:Acronym
Trial of the effect of food ingredients and exercise on muscle function
Region
| Japan |
Condition
Condition
Not applicable
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effect of nutrition and exercise on muscle function
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The amount of changes in femoral muscle cross-sectional area during the 24th week intervention period
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Prevention
Type of intervention
| Food | Behavior,custom |
Interventions/Control_1
Supplementation of low-dose food ingredient and exercise
Interventions/Control_2
Supplementation of high-dose food ingredient and exercise
Interventions/Control_3
Supplementation of placebo and exercise
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 50 | years-old | <= |
Age-upper limit
| 74 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) Women and men aged 50 to 74 years at the time of acquisition of agreement in participating in this study
2) Person who does not engage regular exercise.
3) Person who can come to the medical organization for the measurement at the date of visiting
4) Person who can understand the purpose and content of this study and agree in writing to participate in this study
Key exclusion criteria
1) Presence of disease in locomotor organs affecting the efficacy assessment of this study.
2) Presence of health problems to perform exercise.
3) Use of supplement affecting the data of this study.
4) With previous and present serious disease such as cardiac affection, liver disorder, kidney disorder, cardiovascular disorder, lung disorder, diabetes mellitus.
5) Investigator's judgment for other reason.
Target sample size
54
Research contact person
Name of lead principal investigator
| 1st name | Takayuki |
| Middle name | |
| Last name | Izumo |
Organization
Suntory Wellness Limited
Division name
Institute For Health Care Science
Zip code
619-0284
Address
8-1-1 Seikadai, Seika-cho, Soraku-gun, Kyoto
TEL
050-3182-0630
Takayuki_Izumo@suntory.co.jp
Public contact
Name of contact person
| 1st name | Yuta |
| Middle name | |
| Last name | Otsuka |
Organization
Suntory Wellness Limited
Division name
Institute For Health Care Science
Zip code
619-0284
Address
8-1-1 Seikadai, Seika-cho, Soraku-gun, Kyoto
TEL
050-3182-0671
Homepage URL
Yuta_Otsuka@suntory.co.jp
Sponsor or person
Institute
Suntory Wellness Limited
Institute
Department
Personal name
Funding Source
Organization
Self-funding
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Fukuda Clinic
Address
1-6-1 Miyahara, Yodogawa-ku, Osaka
Tel
06-6398-0203
fukudaclinicIRB@gmail.com
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 02 | Month | 28 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2019 | Year | 08 | Month | 06 | Day |
Date of IRB
| 2019 | Year | 06 | Month | 15 | Day |
Anticipated trial start date
| 2019 | Year | 08 | Month | 10 | Day |
Last follow-up date
| 2020 | Year | 03 | Month | 19 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2019 | Year | 08 | Month | 08 | Day |
Last modified on
| 2021 | Year | 12 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042911
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
